Method for fabricating a sterile ready-pack and a container for such a ready-pack

Abstract

A method for a single step sterilization of a ready-pack, such as a blister pack, in an autoclave is described. The ready pack includes a container, such as a syringe, filled with a substance. The environment in the autoclave, that is, the temperature, the heating period and, preferably, the pressure is controlled to sterilize simultaneously the ready-pack and its contents by circulating steam in the autoclave. The steam penetrates into the blister pack through a steam-permeable base. The temperature is maintained between about 120.degree. C. to 130.degree. C. for about 15-20 minutes.

Claims

1. A method for preparing a sterile ready-pack unit including at least one sterilized ready-pack containing a syringe closed off at one end and made from thermally stable material withstanding up to 130.degree. C., for single use application, said method comprising the step of:

filling a water-containing pharmaceutical substance through an open end into the syringe by utilizing pressure;

closing the open end of the syringe off with a thermally stable cap withstanding up to 130.degree. C.;

inserting the filled syringe into said ready-pack, having a steam-permeable base;

placing the ready-pack into an autoclave;

controllably heating the ready-pack unit in an autoclave by circulating steam-air mixture at a temperature of at least about 120.degree. C. to 130.degree. C. for at least about 15 minutes, so as to simultaneously sterilize the at least one ready-pack, the container and the substance within the container.

2. The method according to claim 1, wherein the duration of time is at least 20 minutes.

3. The method of claim 1, wherein the at least one non-sterilized ready-pack is a plurality of ready-packs.

4. The method of claim 1, further comprising the steps of controlling the autoclave pressure and the moisture of the steam-air mixture during the sterilizing step.

5. The method of claim 1, wherein the ready-pack unit is a folding box and the base is perforated cardboard.

6. The method of claim 1, wherein the base is paper.

7. A method for sterilizing a ready-pack unit, including at least one sealed blister pack containing a syringe with a discharge piston, the syringe containing a water-containing pharmaceutical substance and being made from thermally stable material withstanding up to 130.degree. C., the blister pack having a steam-permeable base, comprising the steps of:

heating the sealed blister-pack with steam to a temperature of about 121.degree. C. for at least about 20 minutes in an autoclave environment, under vacuum conditions, increasing the pressure in the autoclave to atmospheric while cooling down the ready-pack unit, and drying the ready-pack unit by evacuating the autoclave.

8. A method for sterilizing a ready-pack unit having semi-permeable base, and, sealed within, a syringe cylinder including an injection needle and a discharge piston, and made from thermally stable material withstanding up to 130.degree. C., said cylinder being filled with an injectable water-containing pharmaceutical substance, comprising the steps of:

sterilizing the ready-pack in an autoclave, under vacuum, at a temperature of about 121.degree. C. for at least about 20 minutes; and increasing the pressure in the autoclave to atmospheric while cooling down the ready-pack unit.